Safety Study of Imexon Treatment of Patients With Metastatic or Disseminated Malignancy

AmpliMed Corporation18 enrolled

Overview

AMP-011 is a Phase 1 study designed to extend the understanding of the toxicity and pharmacology of imexon by investigating a schedule of daily treatment for 5 days every three weeks. The objective of the study is to determine the maximally tolerated dose, the pharmacokinetics, and the toxicity of the drug on the designated schedule.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neoplasm Metastasis

Interventions

imexonDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Previously treated malignant disease of any type. * Prior treatment; at least one prior regimen required. * Able to perform the activities of daily living. * Off prior cancer therapy for at least 4 weeks. * If female, neither pregnant nor nursing. * Willing to use contraceptives to prevent pregnancy. * No other serious illnesses. * No other active malignancy. * No serious infections. * No other current drug therapy for the cancer. * Blood counts and blood chemistries in or near normal range. * Prior radiation is permitted. Exclusion Criteria: * No active brain metastases.

Locations (4)

US Oncology Indiana

Indianapolis, Indiana, United States

US Oncology Albany, New York Oncology

Albany, New York, United States

Investigational Site 014

Temple, Texas, United States

US Oncology, Tyler Cancer Center

Tyler, Texas, United States

Outcomes

Primary Outcomes

Determine the maximally tolerated dose

determine the pharmacokinetics

determine the toxicity of the drug on the designated schedule

Data from ClinicalTrials.gov

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